APPENDIX PP
RETENTION OF LABORATORY RECORDS AND MATERIALS
The College of American Pathologists makes the following recommendations for the minimum requirements for the retention of laboratory records and materials. They meet or exceed the regulatory requirements specified in the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88). The College of American Pathologists urges laboratories to retain records and/or materials for a longer period of time than specified when such would be appropriate for patient care, education or quality improvement needs. Some state regulations as well as other federal mandates may require retention of records and/or materials for a longer time period than that specified in the CLIA-88 regulations; therefore any applicable state or federal laws should be reviewed carefully when individual laboratories develop their record retention policies.
MATERIAL/RECORD PERIOD OF RETENTION
General Laboratory
Accession log records2 years
Maintenance/instrument maintenance2 years
Quality control records2 years
Surgical Pathology (including bone marrows)
Wet tissue2 weeks after final report
Paraffin blocks10 years
Slides10 years
Reports10 years
Cytology
Slides (negative-unsatisfactory)5 years
Slides (suspicious-positive)5 years
Fine needle aspiration slides10 years
Reports10 years
Non-Forensic Autopsy Records
Wet tissue3 months after final report
Paraffin blocks10 years
Slides10 years
Reports10 years
Forensic Autopsy Records
Wet stock tissue3 years
Paraffin blocksIndefinitely
ReportsIndefinitely
SlidesIndefinitely
Gross photographs/negativesIndefinitely
Accession log recordsIndefinitely
Body fluids and tissues for toxicology1 year
Dried blood stain or frozen tissues for DNAIndefinitely
Clinical Pathology Records
Patient test records2 years
Serum/CSF/Body fluids (except urine)48 hours
Urine24 hours
Peripheral blood smears/body fluid smears7 days
Permanently stained slides – microbiology
(gram, trichrome, etc)7 days
Cytogenetics Records
**Permanent stained slides3 years
**Fluorochrome stained slidesAt the discretion of the laboratory director
Wet specimen/tissueUntil adequate metaphase
cells are obtained Fixed cell pellet 2 weeks after final report
Final reports20 years
Diagnostic images (digitized or negatives)20 years
Blood Bank
Donor10 years
Patient records10 years
Records of employee signatures,
initials, and identification codes10 years
Quality control records5 years
Records of indefinitely deferred donors,Indefinitely
permanently deferred donors, or donors
placed under surveillance for the
recipient’s protection (e.g., those donors
that are Hepatitis B Core positive once,
donors implicated in a hepatitis positive
recipient)
Specimens from blood donors
units and recipients7 days post-transfusion
Adopted 8/95
Revised 9/95
Reaffirmed 8/98
Revised 11/00
Revised 11/01
**Revised 11/04